Hydroxychloroquine for IgA Nephropathy: See If It Helps Manage the Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial investigates the use of hydroxychloroquine, compared with placebo, in adults with biopsy-proven IgA nephropathy who have significant proteinuria and are on optimized RAAS therapy plus SGLT-2 inhibitors. Participants are monitored for safety and kidney-related outcomes while receiving the study drug or placebo. The study builds on the drug’s anti-inflammatory effects and potential to modulate mucosal immunity and IgA pathways. Enrollment requires specific renal histology features, stable concomitant therapies, and reproductive safety measures. Outcomes will inform whether hydroxychloroquine can alter disease course or proteinuria in IgA nephropathy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Social security affiliation
* Signed informed consent
* With biopsy proven IgA nephropathy (any vintage)
* With at least one Oxford lesion (M, E, S, T, C) on last available kidney biopsy - With urine albumin/creatinine \> 300mg/g,
* under maximal tolerated labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors for at least 3 months
* Sodium-Glucose Transport Protein 2 (SGLT-2) inhibitors initiated at least 1 month before inclusion visit
* Only patients treated with SGLT2i and RAAS dual therapy before inclusion
* With estimate GFR above 15 mL/min/1,73m² (Chronic Kidney Disease - EPIdemiology collaboration CKD-EPI formula)
* Woman in childbearing with a highly effective method of contraception
* Agreement of woman in childbearing potential (WOCBP) to perform a urine pregnancy test every month until three months after the end of study treatment
* Agreement of fertile male with WOCBP partner to use a condom for the duration of the study treatment up to 3 months after treatment the end of study treatment.

Exclusion Criteria:

* Secondary IgA nephropathy (Henoch Schonlein purpura, cirrhosis, inflammatory bowel disease)
* Corticosteroid or immunosuppressive therapies in the past year before screening
* Contra-indication to hydroxychloroquine (retinopathy, maculopathy, history of intolerance to hydroxychloroquine…)
* Uncontrolled hypertension (systolic blood pression\> 160 mmHg and/or diastolic blood pression \>110 mmHg )
* Long QT interval and/or QT prolonging medicines
* Pregnancy or lactation

Where it's running

• CHU Gabriel Montpied
  Clermont-Ferrand, France Recruiting
• Hospices Civils de Lyon
  Lyon, France Recruiting
• AP-HM Hôpital de la Conception
  Marseille, France Recruiting
• Chr Metz Thionville Hopital Mercy
  Metz, France Recruiting
• APHP Hôpital Bichat
  Paris, France Recruiting
• APHP Hôpital de Tenon
  Paris, France Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JADE101 in IgA Nephropathy: a Phase 2 test in adults

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• Atrasentan for pediatric primary IgA nephropathy

  This study tests whether atrasentan can help children and teens with primary IgA nephropathy reduce protein in urine.

  Recruiting at 19 sites Phase 3 Novartis · Neptune City, New Jersey and 22 other locations · NCT07498335

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  Recruiting Early Phase 1 Nanjing Bioheng Biotech Co., Ltd. · Shanghai, Shanghai Municipality · NCT07203404

• BHV-1400 for IgA nephropathy

  This study will try BHV-1400 in adults with biopsy-confirmed IgA nephropathy to see if the drug is safe and tolerable.

  Recruiting at 15 sites Phase 1 Biohaven Pharmaceuticals, Inc. · Farmington, Connecticut and 14 other locations · NCT07054684

• Nefecon (budesonide) plus ambrisentan for IgA nephropathy with proteinuria

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  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07030894

• Epithelial Dysmetabolism and Kidney Fibrosis in ANCA Vasculitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.